System for intravascular and non-invasive physiological and vascular parameter sensing

By designing a system that includes wearable devices and probe units, the problem of difficulty in non-invasively accurately measuring physiological and vascular parameters in the prior art is solved, and high-precision parameter measurement and better clinical decision support are achieved.

CN222853861UActive Publication Date: 2025-05-13BECTON DICKINSON & CO
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Patent Information

Application Number
CN202421148762.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Priority Date
2024-05-08
Filing Date
2024-05-24
Publication Date
2025-05-13
Estimated Expiration
2034-05-24

AI Technical Summary

Technical Problem

The prior art is difficult to non-invasively accurately measure physiological and vascular parameters, especially within the vasculature or subcutaneously, and does not provide sufficient accuracy to support clinical decision-making.

Method used

A system consisting of a wearable device and a probe unit is designed, equipped with a probe, sensor and interface that can be inserted into the vasculature or subcutaneously, sense physiological and vascular parameters, and transmit data to the wearable device via wireless or physical coupling.

Benefits of technology

Non-invasive, precise measurement of physiological and vascular parameters is achieved, providing smarter clinical decision-making support, and enhanced tracking and management of patient health.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure generally relates to a system for intravascular and non-invasive physiological and vascular parameter sensing, comprising: a wearable device; and a probe unit configured to be coupled to the wearable device, the probe unit having a probe configured to be inserted into the vasculature or subcutaneously to sense one or more physiological or vascular parameters and to deliver the one or more physiological or vascular parameters to the wearable device. An object of one aspect of the present application is to provide a system for intravascular and non-invasive physiological and vascular parameter sensing. The technical effect of one aspect of the application is to provide a system for intravascular and non-invasive physiological and vascular parameter sensing.
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Description

Technical Field

[0001] The present disclosure relates to systems for intravascular and non-invasive physiological and vascular parameter sensing. Background Art

[0002] Health apps and wearable devices that can non-invasively measure physiological parameters have become a very popular and increasingly important way for consumers and users to provide important health tracking and monitored health information to better manage their activities, lifestyles and certain chronic health conditions. While this technology has advanced, certain physiological parameters can only be measured from within the vasculature (venous or arterial), subcutaneously or via smart implantable devices, or can only be measured with sufficient accuracy to inform clinical decisions.

[0003] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as described above. Rather, this background is merely provided to illustrate one example technology area where some embodiments described herein may be practiced. Utility Model Content

[0004] An object of one aspect of the present application is to provide a system for intravascular and non-invasive physiological and vascular parameter sensing.

[0005] The present disclosure generally relates to systems for intravascular and non-invasive physiological and vascular parameter sensing. A system may include a wearable device such as a watch and a probe unit having a probe that can be inserted into the vasculature or subcutaneously to sense physiological and / or vascular parameters and send such parameters to the wearable device. The probe unit can be directly coupled to the wearable device or wirelessly coupled. The system may also include a parameter sensing patch that can sense additional physiological and / or vascular parameters. Physiological and vascular parameters can enable clinicians to make more informed decisions and can enhance tracking of improvements or deteriorations in a patient's health status. The use of physiological and vascular parameters can be particularly beneficial when a patient is receiving medication or fluid intervention or a treatment plan.

[0006] In some embodiments of the present disclosure, a system for intravascular and non-invasive physiological and vascular parameter sensing may include a wearable device and a probe unit configured to be coupled to the wearable device. The probe unit may have a probe configured to be inserted into a vascular system or subcutaneously to sense one or more physiological or vascular parameters and deliver the one or more physiological or vascular parameters to the wearable device.

[0007] In some embodiments, the probe unit may be physically coupled to the wearable device.

[0008] In some embodiments, the probe unit may be physically coupled to a strap of the wearable device.

[0009] In some embodiments, the probe unit may be physically coupled to a computing unit of the wearable device.

[0010] In some embodiments, the probe unit may include a base unit from which the probe extends and an interface connected to the base unit, the interface being physically coupled to the wearable device.

[0011] In some embodiments, the probe unit may include a base unit that is wirelessly coupled to a computing unit of the wearable device.

[0012] In some embodiments, the probe may include one or more sensors that sense the one or more physiological or vascular parameters.

[0013] In some embodiments, the probe unit may include a platform.

[0014] In some embodiments, the one or more physiological or vascular parameters may include one or more of pH, lactate, glucose, arterial or venous core temperature, blood pressure, oxygenation level, presence of microorganisms, blood chemistry, blood gases, or electrolytes.

[0015] In some embodiments, the wearable device may include a computing unit that displays the one or more physiological or vascular parameters.

[0016] In some embodiments, the wearable device may be a watch, and the probe unit may be coupled to a strap of the watch.

[0017] In some embodiments, the system may include a parameter sensing patch configured to communicate with the probe unit.

[0018] In some embodiments, the probe unit can be configured to be inserted into a vascular access device to position the probe within the vasculature or subcutaneously.

[0019] In some embodiments, the system may include a server configured to receive the one or more physiological or vascular parameters from the wearable device.

[0020] In some embodiments, the server may be configured to process the one or more physiological or vascular parameters using an artificial intelligence algorithm to detect or predict the occurrence of a health condition.

[0021] In some embodiments of the present disclosure, a system for intravascular and non-invasive physiological and vascular parameter sensing may include a watch and a probe unit. The probe unit may have a base unit from which the probe extends. The base unit may be configured to couple to the watch. The probe may be configured to sense one or more physiological or vascular parameters when positioned in the individual's vasculature or subcutaneously when the individual wears the watch.

[0022] In some embodiments, the probe unit may include an interface that plugs into a socket in the watch.

[0023] In some embodiments, the jack may be formed on a strap of the watch or in a computing unit of the watch.

[0024] In some embodiments, the probe unit may be wirelessly coupled to the watch.

[0025] In some embodiments of the present disclosure, a system for intravascular and non-invasive physiological and vascular parameter sensing may include a watch with a band and a probe unit, the probe unit having a base unit, a probe with one or more sensors, and an interface. When the probe is inserted into the vascular system or subcutaneous of an individual, the one or more sensors may generate one or more physiological or vascular parameters. The interface may be inserted into a jack of the band to form an electrical connection between the base unit and a computing unit of the watch for transmitting the one or more physiological or vascular parameters.

[0026] A technical effect of one aspect of the present application is to provide a system for intravascular and non-invasive physiological and vascular parameter sensing.

[0027] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, rather than limiting, the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined without departing from the scope of the various embodiments of the invention, or other embodiments may be utilized, and structural changes may be made unless so required. Therefore, the following detailed description should not be understood as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0029] Figure 1 Examples of systems for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure are provided;

[0030] Figure 2Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided;

[0031] Figure 3 Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided;

[0032] Figure 4 Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided;

[0033] Figure 4A and Figure 4B Pictured Figure 4 changes in the system;

[0034] Figure 5 An example is provided of how to insert a probe unit of a system for intravascular and non-invasive physiological and vascular parameter sensing into the vasculature of an individual;

[0035] Figure 6 Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided;

[0036] Figure 7 Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided;

[0037] Figure 8 Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided; and

[0038] Fig. 9

[0013] Another example of a system for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. DETAILED DESCRIPTION

[0039] Figure 1 An example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured according to one or more embodiments of the present disclosure is provided. The system 50 includes a wearable device 100 and a probe unit 200. In some embodiments, such as the illustrated embodiment, the wearable device 100 may take the form of a watch (or bracelet) that includes a computing unit 101 and a band 102 to enable the wearable device 100 to be worn around a wrist.

[0040] Probe unit 200 may include probe 201, one or more sensors 202, platform 203, base unit 204 and interface 205. Probe 201 is configured to be inserted into the vascular system of an individual or subcutaneously. In some embodiments, probe 201 may include a core wire, such as a nitinol wire extending along the length of probe 201, for structure and durability during advancement. In some embodiments, probe 201 may include a non-destructive tip. In some embodiments, probe 201 may include a fluid path so that blood can be drawn or aspirated via probe unit 200.

[0041] In some embodiments, the probe 201 may include coatings to improve performance or reduce the risk of complications such as thrombosis or probe-related bloodstream infection. These coatings may include silicone lubricants, which may or may not contain antimicrobial additives such as CH(x). In some embodiments, the probe 201 may be coated with an antithrombotic or antimicrobial coating or polymer additive.

[0042] Sensor 202 can be positioned on / in probe 201, where sensor 202 will be in contact with blood, tissue, etc. to sense one or more physiological or vascular parameters below the surface of the skin. In some embodiments, base unit 204 can include circuitry for controlling sensor 202 and / or communicating with sensor 202 (e.g., via optical fibers or wires). Platform 203 can support base unit 204 when placed on the surface of the skin.

[0043] The interface 205 is a physical and electrical interface for coupling the probe unit 200 to the wearable device 100. Figure 1 In the embodiment of the present invention, the band 102 of the wearable device 100 includes a socket 103 for receiving the interface 205. One or more leads 104 can be integrated into the band 102, and can form a contact 104a for connecting the lead 104 to a corresponding contact on the computing unit 101 and a contact 104b for connecting the lead 104 to a corresponding contact on the interface 205. In other words, when the interface 205 is inserted into the socket 103, an electrical connection is established between the computing unit 101 and the base unit 204, so that the computing unit 101 can obtain data indicating the one or more physiological or vascular parameters generated by the sensor 202. In some embodiments, the lead 104 can also provide power to the base unit 204. However, in other embodiments, the base unit 204 can be independently powered (e.g., via a battery).

[0044] The socket 103 can be positioned and oriented on the band 102 so that the probe 201 can be inserted into the individual's vasculature or subcutaneously while the interface 205 is inserted into the socket 103. For example, in Figure 1In the configuration shown in , the probe 201 can be inserted into a vein located at the underside of an individual's wrist. Once the probe 201 is correctly positioned, a fixation dressing (not shown) can be placed on the platform 203 to fix the probe 201 in place.

[0045] In some embodiments, the sensor 202 may be configured to sense one or more blood-based parameters, such as pH, lactate, glucose, arterial or venous core temperature, blood pressure, oxygenation level, presence of microorganisms, blood chemistry, blood gases, electrolytes, etc. In some embodiments, the computing unit 101 may be configured to display such parameters (e.g., via an application) and / or transmit such parameters to another system (e.g., to a server). In some embodiments, the computing unit 101 may also be configured to display additional parameters, such as heart rate, irregular heart rhythm, ECG, low cardiovascular health, blood oxygen level, fall detection, etc.

[0046] Figure 2 Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. In addition to the base unit 204 being configured to wirelessly communicate with the computing unit 101, Figure 2 The system 50 shown in FIG. Figure 1 Thus, the probe unit 200 does not include the interface 205 and the strap 102 does not include the socket 103 or the lead 104.

[0047] Figure 3 Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. In addition to the base unit 204 being connected to the interface 205 via the tether 206, Figure 3 The system 50 shown in FIG. Figure 1 This configuration provides greater flexibility in placing the probe 201.

[0048] Figure 4

[0046] Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. Figure 4 The system 50 shown in FIG. Figure 2The system 50 is similar to the system 50 of the present invention, but a parameter sensing patch 300 is added. The parameter sensing patch 300 can have a base 301, which is configured to adhere to the skin of an individual and can be configured to sense additional physiological and vascular parameters, such as vitals. In some embodiments, both the base unit 204 and the parameter sensing patch 300 can be configured to wirelessly transmit the physiological and vascular parameters to the computing unit 101. In other embodiments, the base unit 204 can be configured to wirelessly transmit the physiological and vascular parameters to the parameter sensing patch 300, which can then relay such parameters and possible additional parameters to the computing unit 101. In some embodiments, the system 50 can include only the probe unit 200 and the parameter sensing patch 300. In other words, in embodiments including the parameter sensing patch 300, the wearable device 100 may not be used.

[0049] Figure 4A A variation is shown in which the parameter sensing patch 300 includes a socket 302 for receiving an interface 205 , which is connected to a base unit 204 via a tether 206 . Figure 4B A variation is shown in which the interface 205 is directly connected to the base unit 204 and plugged into the socket 302 .

[0050] Figure 5 An example of how the probe unit 200 can be used to sense physiological and vascular parameters from within the vascular system 500 of an individual is provided. The probe 201 can be inserted into the vascular system 500 (or subcutaneously) in any suitable manner, such as via direct placement or via a catheter. With the probe 201 inserted, the platform 203 can be secured to the skin of the individual, such as via an adhesive on the bottom of the platform 203 and / or via a fixed dressing.

[0051] Figure 6

[0046] Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. Figure 6 The system 50 shown in FIG. Figure 1 The system in FIG. 20 is the same. However, the probe unit 200 does not include a platform. Instead, the socket 103 can play the role of supporting the base unit 204. Figure 6 Also shown is how interface 205 may include contacts 205a that may establish electrical connection with contacts 104b when interface 205 is inserted into socket 103. In some embodiments, socket 103 and interface 205 may include guides, magnets, or other mechanisms to ensure that contacts 205a will align with contacts 104b.

[0052] Figure 7Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. Figure 7 , the computing unit 101 has a different configuration than in the previous figures.

[0053] Figure 8 Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. Figure 8 In the embodiment of the present invention, the socket 103 is formed in the computing unit 101 instead of the band 102. The interface 205 also includes a guide 207 (eg, a notch or a protrusion) for fixing the interface 205 in the socket 103. The strain relief 201a may also be formed at the base of the probe 201.

[0054] Fig. 9 Another example of a system 50 for intravascular and non-invasive physiological and vascular parameter sensing configured in accordance with one or more embodiments of the present disclosure is provided. Fig. 9 8, the probe unit 200 is shown inserted into the vascular system of an individual via a vascular access device 800. In particular, the probe 201 can be inserted through a port 802 of the vascular access device 800 and passed out through a catheter 801. The length of the probe 201 can be configured to extend the probe from the catheter 801 when the base unit 204 is inserted into the port 802. In these embodiments, the system 50 may or may not include a parameter sensing patch 300. Moreover, in these embodiments, the probe unit 200 may include a tether 206 for connecting the base unit 204 to the computing device 100 or the parameter sensing patch 300.

[0055] The physiological and vascular parameters that can be obtained via system 50 can enable clinicians to make more informed decisions and can enhance tracking of improvements or deterioration in a patient's health status. The use of physiological and vascular parameters can be particularly beneficial when a patient is undergoing a medication or fluid intervention or treatment plan.

[0056] As suggested above, in some embodiments, system 50 can include a server system (e.g., a cloud-based system) that can receive, process, and store physiological and vascular parameters (e.g., as part of a patient's electronic medical record). Such a server system can enable the physiological and vascular parameters to be displayed to a clinician who may be monitoring the patient (e.g., at a nurse's station). In some embodiments, the server system can process the physiological and vascular parameters and then relay those parameters, or data derived from those parameters, to an application on computing unit 101 for display. In some embodiments, the server system can include an artificial intelligence engine that can process the physiological and vascular parameters to automatically detect or predict the occurrence of a condition.

[0057] In some embodiments, computing unit 101 or another computing device can be configured to output an alarm based on the physiological and vascular parameters. For example, an application or dedicated user interface component on computing unit 101 can be configured to output a visual, auditory, tactile, or digital alarm or sign. In some embodiments, computing unit 101 or other devices (e.g., infusion pumps, vital signs monitors, arterial monitors, ultrasound system visual displays, smart phones, tablet computers, etc.) can respond to such alarms or signs, or directly respond to physiological and vascular parameters to capture data or images for storage with the physiological and vascular parameters.

[0058] All examples and conditional language described herein are intended for teaching purposes to help readers understand the utility model and the concepts contributed by the inventor to promote the art, and should be interpreted as not being limited to such specifically described examples and conditions. Although the embodiments of the utility model have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the utility model.

Claims

1. A system for intravascular and non-invasive physiological and vascular parameter sensing, characterized in that include: Wearable devices; as well as A probe unit is configured to be coupled to a wearable device, the probe unit having a probe configured to be inserted into a vascular system or subcutaneously to sense one or more physiological or vascular parameters and deliver the one or more physiological or vascular parameters to the wearable device.

2. The system according to claim 1, characterized in that The probe unit is physically coupled to the wearable device.

3. The system according to claim 1, characterized in that The probe unit is physically coupled to the strap of the wearable device.

4. The system according to claim 1, characterized in that The probe unit is physically coupled to the computing unit of the wearable device.

5. The system according to claim 1, wherein: The probe unit includes a base unit from which the probe extends and an interface connected to the base unit, the interface being physically coupled to the wearable device.

6. The system according to claim 1, characterized in that The probe unit includes a base unit that is wirelessly coupled to a computing unit of the wearable device.

7. The system according to claim 1, characterized in that The probe includes one or more sensors that sense the one or more physiological or vascular parameters.

8. The system of claim 1, wherein: The probe unit includes a platform.

9. The system according to claim 1, characterized in that The one or more physiological or vascular parameters include one or more of: pH, lactate, glucose, arterial or venous core temperature, blood pressure, oxygenation level, presence of microorganisms, blood chemistry, blood gases, or electrolytes.

10. The system according to claim 9, characterized in that The wearable device includes a computing unit that displays the one or more physiological or vascular parameters.

11. The system according to claim 1, characterized in that The wearable device is a watch, and wherein the probe unit is coupled to a strap of the watch.

12. The system of claim 1, wherein: Also includes: The parameter sensing patch is configured to communicate with the probe unit.

13. The system of claim 1, wherein: The probe unit is configured to be inserted into a vascular access device to position the probe in the vasculature or subcutaneously.

14. The system of claim 1, wherein: Also includes: The server is configured to receive the one or more physiological or vascular parameters from the wearable device.

15. The system of claim 14, wherein: The server is configured to process the one or more physiological or vascular parameters using an artificial intelligence algorithm to detect or predict the occurrence of a health condition.

16. A system for intravascular and non-invasive physiological and vascular parameter sensing, characterized in that include: watch; as well as A probe unit having a base unit from which a probe extends, the base unit being configured to couple to a watch, the probe being configured to sense one or more physiological or vascular parameters when positioned in the individual's vasculature or subcutaneously when the individual is wearing the watch.

17. The system of claim 16, wherein: The probe unit comprises an interface which plugs into a socket of the watch.

18. The system of claim 17, wherein: The socket is formed on the strap of the watch or in the computing unit of the watch.

19. The system of claim 16, wherein: The probe unit is wirelessly coupled to the watch.

20. A system for intravascular and non-invasive physiological and vascular parameter sensing, characterized in that include: Wristwatch, with strap; as well as A probe unit having a base unit, a probe having one or more sensors, and an interface, wherein when the probe is inserted into the vascular system or subcutaneously of an individual, the one or more sensors generate one or more physiological or vascular parameters, and wherein the interface is inserted into a socket of the strap to form an electrical connection between a computing unit of the watch and the base unit for transmitting the one or more physiological or vascular parameters.